Name: Predicase
Price: 199 USD

K-number	K252874
Device name	Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
Applicant	Serpex Medical, Inc.
Product code	KTI
Device class	Class II
Decision date	Oct 8, 2025
Decision	Substantially Equivalent
Regulation	874.4680

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01

Everything you need for a 510(k) submission. Nothing you don't.